AccessGUDID - DEVICE: Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2) (00792293063908)

GUDID

Device Identifier (DI) Information

Brand Name: Urocare® Universal Fabric Leg Bag Straps with Velcro® Closue (Set of 2)
Version or Model: 6390
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6390
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293063908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: STRAP, LEG BAG, LATEX-FREE, VELCRO, UNIVERSAL, REUSABLE For use with most vinyl disposable or latex reusable leg bags. They are an economical alternative to the standard latex rubber straps packaged with most urine collection bags. An elastic/cotton & body construction allows the self-gripping fastener to attach itself along the length of the strap making it fully adjustable to individual requirements providing a safe, secure hold with a comfortable fit. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 2 Universal Leg straps and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE STRAP LOOPS/EYELETS FOR STRAPS TO PASS THROUGH

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.06 Pound
Device Size Text, specify: Fits: 8" ~ 24" DIA. (20cm ~ 61cm Ø)
Device Size Text, specify: Universal, One size fits all Suitable for 44 fl. oz. (1,3 L) leg bags or smaller.

Device Record Status

Public Device Record Key: 7ca2fb52-e61f-4e4c-8f60-d1604373a740
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 29, 2018